Comparing intranasal and subcutaneous ketamine for treating acute pain in the emergency department
Intranasal Ketamine Versus Subcutaneous Ketamine for Treatment of Post Traumatic Acute Pain in the Emergency Department
This study is testing whether a nasal spray or an injection of ketamine works better to relieve pain for adults with acute limb injuries in the emergency department.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Monastir Academic / other |
| Locations | 1 site (Monastir) |
| Trial ID | NCT05229055 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intranasal ketamine compared to subcutaneous ketamine for managing acute limb trauma pain in emergency department patients. It is a randomized, double-blind, controlled study conducted across three community teaching hospitals in Tunisia. Participants aged 18 to 60 with a visual analog scale (VAS) pain score of 5 or more will receive either intranasal or subcutaneous ketamine. The study aims to determine which method provides better pain relief for patients experiencing acute trauma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 who present to the emergency department with acute limb trauma pain rated 5 or higher on a pain scale.
Not a fit: Patients with altered mental status, severe medical histories, or those who have recently used analgesics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and rapid pain management option for patients with acute trauma in emergency settings.
How similar studies have performed: Previous studies have shown promising results for intranasal ketamine in pain management, but the comparison with subcutaneous administration in trauma patients is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11 point (0-10). * Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb. Exclusion Criteria: * Pregnancy/Breastfeeding * altered mental status (GCS\<15) * Allergy to ketamine or morphine * Weight less than 40 kg or greater than 100kg * Unstable vital signs (systolic blood pressure \<90 or \> 180mmHg, pulse rate\<50 or \>150bpm, and respiration rate \<10 or \>30 breath/min) * Medical history of acute head or eye injury * Medical history of seizure * Medical history of intracranial hypertension, * Medical history of chronic pain, * Medical history of severe renal or hepatic insufficiency. * Medical history of glaucoma * Alcohol or drug abuse * Psychiatric illness, * Recent (4 hours before) analgesic agent use.
Where this trial is running
Monastir
- university of Monastir — Monastir, Tunisia (Recruiting)
Study contacts
- Principal investigator: Nouira Semir, Professor — University of Monastir
- Study coordinator: Nouira Semir, Professor
- Email: semir.nouira@rns.tn
- Phone: 73106046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.